Introduction: Data on anatomical and functional outcomes and late complications of vaginal meshes used in the treatment of genital prolapse are limited. Restorelle® DirectFixTM is a 4-arm ultra-light (19 g / m2) single-incision mesh, made of porous macro-polypropylene. The proximal arms of the mesh are sutured to the sacro spinous ligament and the distal arms of the mesh in the arcus tendinous fascia pelvis . We have previously shown that the feasibility is good and that the rate of early complications acceptable.

Objective:To determine the frequency of delayed postoperative complications associated with the placement of Restorelle® DirectFix ™ anterior and/or posterior in the treatment of prolapse and to present anatomical and functional results at least 1 year after surgery.

Methods: This is a French retrospective multi-center series including 91 patients operated by vaginal approach with a Restorelle® DirectFixTM , whether or not they had another surgical procedure. The primary endpoint was the occurrence of delayed postoperative complications (> 31 days post operative). Secondary outcomes were anatomical and functional results.

Results: The 91 included patients operated in 8 centers by 10 surgeons between January 2013 and December 2016 had a consultation at 12 months postoperative or after or had been reached by phone. The average age of the patients was 70 ± 9 years old. 18.7% of patients had a history of prolapse surgery. According to the POP-Q classification, 100%, 58.6% and 37.4% of patients had respectively cystocele, prolapse of apex and rectocele of stage 2 or more. Delayed postoperative complications were: self-catheterization (1.1%), recurrent urinary tract infections (3.3%), de novo urinary stress incontinence (4.4%), chronic pain (2.2%), mesh exposure (3.1%), recurrence of prolapse (15.6%), surgical revision (9.4%), need of Botox for overactive bladder (1.1%). We did not find any association between complication and age, body mass index, surgical history, prolapse stage and associated procedures (suburethral sling, autologous repair),except associated hysterectomy that tends to increase the risk of delayed complication (p=0,06). At 12 months or more postoperative, 71% of patients who had an anterior Restorelle had no cystocele or stage 1 cystocele; 90% of patients who had an anterior or an posterior Restorelle had no apex prolapse or stage 1 apex prolapse; 94% of patients who had an posterior Restorelle had no rectocele or stage 1 rectocele. 84.3% of patients were satisfied or very satisfied with the progression of symptoms since surgery.

Conclusions: According to this series of we conclude that POP repair with anterior Restorelle® mesh has a good feasibility and safetyness. Nonetheless patients should have detailed preoperative counseling of the risks of POP surgery with and without mesh. These results should be completed by studies assessing long term functional and anatomical results and comparative series. However, the use of this ultra-light mesh seems promising in terms of tolerance (exposure, pain/dyspareunia).

Disclosure:

Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Coloplast).